No registrations found.
ID
Source
Brief title
Health condition
Gut adaptation and modulation of the immune response in very low birth weight infants.
Sponsors and support
Department of Pediatrics
Division of Neonatology
De Boelelaan 1117
1081 HV Amsterdam
Netherlands
Tel: +31 20 4442413
Fax: +31 20 4443045
Email: w.fetter@vumc.nl
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is time to full enteral feeding, defined as a feeding volume ¡Ý120 mL/kg/day.
Secondary outcome
Furthermore, other parameters of feeding tolerance, infectious morbidity, and short-term outcome are evaluated. In addition to clinical outcome, intestinal permeability, faecal flora, plasma Th1/Th2 cytokine concentrations and plasma amino acid profiles are determined during the 30 day study period.
Background summary
Background:
Enteral feeding of very low birth weight (VLBW) infants is a challenge, since metabolic demands are high and administration of enteral nutrition is limited by immaturity of the gastrointestinal tract. The amino acid glutamine plays an important role in maintaining functional integrity of the gut. In addition, glutamine is utilised at a high rate by cells of the immune system. In critically ill patients, glutamine is considered a conditionally essential amino acid. VLBW infants may be especially susceptible to glutamine depletion as nutritional supply of glutamine is limited in the first weeks after birth. Glutamine depletion has negative effects on functional integrity of the gut and leads to immunosuppression.
This double-blind randomised controlled trial is designed to investigate the effect of glutamine-enriched enteral nutrition on feeding tolerance, infectious morbidity and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of glutamine in postnatal adaptation of the gut and modulation of the immune response.
Methods:
VLBW infants (gestational age <32 weeks and/or birth weight <1500 g) are randomly allocated to receive enteral glutamine supplementation (0.3 g/kg/day) or isonitrogenous placebo supplementation between day 3 and 30 of life. Primary outcome is time to full enteral feeding (defined as a feeding volume ¡Ý120 mL/kg/day). Furthermore, incidence of serious infections and short-term outcome are evaluated. The effect of glutamine on postnatal adaptation of the gut is investigated by measuring intestinal permeability and determining faecal microflora. The role of glutamine in modulation of the immune response is investigated by determining plasma Th1/Th2 cytokine concentrations following in vitro whole blood stimulation.
Study objective
VLBW infants may be susceptible to glutamine depletion as nutritional supply of glutamine is limited in the first weeks after birth. Glutamine depletion has negative effects on functional integrity of the gut and leads to immunosuppression. This double-blind randomised controlled trial is designed to investigate the effect of glutamine-enriched enteral nutrition on feeding tolerance, infectious morbidity and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of glutamine in postnatal adaptation of the gut and modulation of the immune response.
Study design
N/A
Intervention
Enteral glutamine supplementation in a dose of 0.3 g/kg/day between days 3 and 30 of life versus isonitrogenous placebo supplementation (alanine).
De Boelelaan 1117
A. Berg, van den
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442413
a.vandenberg@vumc.nl
De Boelelaan 1117
A. Berg, van den
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442413
a.vandenberg@vumc.nl
Inclusion criteria
Infants with a gestational age < 32 weeks and/or a birth weight < 1500 grams.
Exclusion criteria
Major chromosomal or congenital anomalies.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL169 |
| NTR-old | NTR205 |
| Other | : N/A |
| ISRCTN | ISRCTN73254583 |
Summary results
Anemone van den Berg, Ruurd M. van Elburg, Jos W.R. Twisk, Willem P.F. Fetter. Biomed Central Pediatrics 2004;4:17.<br>
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2. Glutamine-enriched enteral nutrition in very-low-birth-weight infants and effects on feeding tolerance and infectious morbidity: a randomized controlled trial.
Anemone van den Berg, Ruurd M. van Elburg, Elisabeth A.M. Westerbeek, Jos W.R. Twisk, Willem P.F. Fetter. American Journal of Clinical Nutrition 2005;81:1397-1404.<br>
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3. A randomized controlled trial of enteral glutamine supplementation in very low birth weight infants: Plasma amino acid concentrations.
Anemone van den Berg, Ruurd M. van Elburg, Tom Teerlink, Harrie N. Lafeber, Jos W.R. Twisk, Willem P.F. Fetter. Journal of Pediatric Gastroenterology and Nutrition 2005;41:66-71. <br>
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4. JPEN J Parenter Enteral Nutr. 2006 Sep-Oct;30(5):408-14.<br>